沛嘉醫療-B(09996.HK):美國JenaValve就用於治療主動脈瓣反流及主動脈瓣狹窄的若干專有經導管主動脈瓣置換產品向公司授出獨佔許可
格隆匯1月14日丨沛嘉醫療-B(09996.HK)公佈,集團近期已與美國醫療器械公司JenaValve Technology, Inc.(許可方)訂立合作及許可協議、服務協議及股份購買協議。根據該等協議,JenaValve已就用於治療主動脈瓣反流及主動脈瓣狹窄的若干專有經導管主動脈瓣置換(TAVR)產品向集團授出獨佔許可。集團有權於大中華區開發、製造及商業化有關產品,而許可方同意提供服務、協助集團開發該地區內有關產品的價值。集團亦已收購JenaValve的若干優先股股份,相當於對許可方的少量股權投資。
主動脈瓣反流是主動脈瓣疾病中最常見的類型之一。根據弗洛斯特沙利文,於2020年,全球約有2700萬名患者及中國約有390萬名患者患有主動脈瓣反流。患有主動脈瓣狹窄時亦常見主動脈瓣反流。然而,許多主動脈瓣反流的患者並無瓣環及瓣葉鈣化,這使得錨定和夾持瓣葉具有挑戰性。目前,中國批准的幾乎所有TAVR產品僅適用於治療主動脈瓣狹窄,而非主動脈瓣反流。中國並無批准用於治療主動脈瓣反流的經股動脈TAVR產品。因此,對於能夠治療主動脈瓣反流的微創TAVR產品的龐大需求仍未得到滿足。
JenaValve為一傢俬人公司,總部位於美國加利福尼亞州爾灣市,於美國加利福尼亞州爾灣市及英國利茲設有製造及組裝基地。由JenaValve開發的Trilogy?心臟瓣膜系統為同類產品中首個及唯一一個獲得CE標誌批准用於治療嚴重的症狀性主動脈瓣反流及主動脈瓣狹窄的經股動脈裝置。該系統憑藉着其獲專利的定位器技術,獨特的系統來定位原生瓣葉。將定位器夾在患者的自然解剖結構上,以確保瓣膜的穩定性。瓣膜的獨特設計亦可對齊解剖瓣膜,從而有助於未來冠狀動脈介入治療及有利於後續長期的血流動力學,兩者均具有治療主動脈瓣反流的顯著臨牀優勢。該系統亦獲得美國食品藥品監管管理局的突破性器械認證。
通過增加一流的主動脈瓣反流治療系統,公司認為此次交易為其壯大TAVR產品線至關重要的一步,並期望通過將產品線適應症擴展到主動脈瓣反流,並提供經臨牀證明的微創治療手段,令更多的中國患者受惠。公司目前擁有兩款經國家藥監局審批的TAVR產品,包括TaurusOne及TaurusElite,以及三款用於治療嚴重主動脈瓣狹窄的在研產品,即TaurusWave(非植入衝擊波治療系統)、TaurusNXT(非醛交聯乾瓣TAVR系統)及TaurusApex(下一代高分子瓣葉TAVR系統)。此次交易將使公司相較於中國其他同業擁有最全面的涵蓋主要主動脈瓣疾病的TAVR產品線。
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